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`Food and Drug Administration
`Silver Spring MD 20993
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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 022567/S-001
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`Reference ID: 3018048
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` SUPPLEMENT APPROVAL
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` Forest Laboratories, Inc.
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`Attention: Kimberly Fabrizio
`Vice President Regulatory Affairs
`Harborside Financial Center
`Plaza V, Suite 1900
`Jersey City, NJ 07311
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`Dear Ms. Fabrizio:
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`Please refer to your Supplemental New Drug Application (sNDA) dated April 29, 2011 (NDA
`022567/S-001), submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act
`(FDCA) for Viibryd (vilazodone hydrochloride) 10 mg, 20 mg, and 40 mg tablets.
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`We also acknowledge receipt of your amendment dated May 2, 2011.
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`This “Changes Being Effected” labeling supplemental new drug application provides for general
`editorial revisions that include information to reflect Forest as the distributor of Viibryd.
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`We have completed our review of this supplemental application, as amended. It is approved,
`effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling
`text as communicated in an email dated June 24, 2011 between yourself and Bill Bender, of this
`Agency.
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`CONTENT OF LABELING
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`Within 14 days, amend all pending supplemental applications for this NDA, including CBE
`supplements for which FDA has not yet issued an action letter, with the content of labeling
`[21 CFR 314.50(l)(1)(i)] in MS Word format, that includes the changes approved in this
`supplemental application, as well as annual reportable changes and annotate each change. To
`facilitate review of your submission, provide a highlighted or marked-up copy that shows all
`changes, as well as a clean Microsoft Word version. The marked-up copy should provide
`appropriate annotations, including supplement number(s) and annual report date(s).
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
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`NDA 022567/S-001
`Page 2
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`If you have any questions, call Bill Bender, Regulatory Project Manager, at (301) 796-2145.
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`Sincerely,
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` {See appended electronic signature page}
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`Thomas Laughren, M.D.
`Director
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`Division of Psychiatry Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
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`ENCLOSURE: Content of Labeling (package insert and Medication Guide)
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`Reference ID: 3018048
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`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
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`THOMAS P LAUGHREN
`09/21/2011
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`Reference ID: 3018048
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